Product code PZJ

Device name

Lynch Syndrome Test System

Medical specialty

Immunology

Device class

2

Regulation number

864.1866

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome

Source

FDA openFDA device classification dataset